FDA Device recall Z-0535-2020
FoundationOne CDx test report
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of FoundationOne CDx test report by Foundation Medicine, citing identified potential false positive MSI-H on the test reports provided to the physicians.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0535-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-08 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Foundation Medicine |
| Distribution | GA, IN, MA, NC, OH |
Product
FoundationOne CDx test report
Reason
Identified potential false positive MSI-H on the test reports provided to the physicians.
Identifiers
| code_info | Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Foundation Medicine
- Hamilton Microlab STAR Liquid Handler
FDA Device · Class II · 2026-08-26 · Foundation Medicine - Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tria…
FDA Device · Class II · 2026-04-29 · Foundation Medicine - Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Device · Class II · 2026-04-29 · Foundation Medicine - FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine - FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine
All Foundation Medicine recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2020%22
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